DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-88 were originally filed June 6, 2023.
The amendment received June 9, 2023 amended claims 2, 7-11, 13, 14, 23, 24, 26, 35, 40, 43, 48, 49, and 78 and canceled claims 3, 12, 15-22, 27-34, 36-39, 41, 42, 50-71, 73-77, and 79-88.
The amendment received October 27, 2023 amended clams 2, 7-11, 13, 14, 23, 24, 26, 35, 40, 43, 48, 49, and 78 and canceled claims 4-6 and 44-47.
The amendment received January 26, 2026 amended claims 10, 26, and 78; canceled claims 25, 35-42, 48, and 72; and added new claims 89-93.
The amendment received August 3, 2026 amended claims 1, 7, 14, 26, 89, 91, and 93; canceled claims 28-11, 13, 23, 24, and 92; and added new claims 93-103.
Claims 1, 7, 14, 26, 43, 49, 78, 89-91, and 93-103 are currently pending.
Claims 1, 89-91, and 93 are currently under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 7-11, 13, 14, 23, and 24; new claims 89-93) in the reply filed on January 26, 2026 is acknowledged.
Claims 26, 43, 49, and 78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected products and methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 26, 2026.
Applicant’s election without traverse of SEQ ID NO: 5, PBS, BSA, and CRM197 as the species in the reply filed on January 26, 2026 is acknowledged.
Please note: elections of subgenuses (i.e. saline, formulation as a solution comprising a carrier protein, the solution further comprises a carrier protein that increases delivery across the BBB) are considered nonresponsive. In addition, the election of species is not optional (i.e. “for example”). The election of species should be definitive.
Please note: SEQ ID NO: 5 is known in the art as secretoneurin which is a cleavage product of present SEQ ID NO: 4 (i.e. residues 182-214 of human precursor SCG2; see paragraphs 125 and 140 of the present specification).
Claims 7, 14, and 94-103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 26, 2026.
Please note: claims 10, 11, and 13 should be withdrawn due to the election of SEQ ID NO: 5. However, due to issues with the claims, the claims have been examined. This does not preclude the withdrawal of the claims at a later date or a new species requirement.
Please note: due to the amendments to claims 7 and 14, the claims are now drawn to nonelected species and are now withdrawn. The original species election is an election by original presentation and can not be altered during prosecution.
Please note: new claims 94-103 are drawn to nonelected species. The original species election is an election by original presentation and can not be altered during prosecution.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/US2021/061950 filed December 6, 2021 which claims the benefit of 63/122,156 filed December 7, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 3, 2026 is being considered by the examiner.
Withdrawn Objections
The objection to the disclosure regarding the nucleic acids in paragraphs 40-43, 184-187, and 438 and pages 105 and 106 should be in lower case is withdrawn in view of the amendment received August 3, 2026.
The objection to the disclosure regarding the amino acids in Table 3 (SEQ ID NOs: 45, 50, 52, 64, and 67) and in paragraphs 208 and 298-300 should be in upper case is withdrawn in view of the amendment received August 3, 2026.
The objection to claim 7 regarding a single conjunction of “and” should be present in the Markush group (see line 7 – missing conjunction) is withdrawn in view of the amendment received August 3, 2026.
The objection to claim 7 regarding “or” should be removed form lines 3, 5, 6, and 7 is withdrawn in view of the amendment received August 3, 2026.
The objection to claim 7 regarding non-elected subject matter is present in the claim (i.e. formulation as a nucleic acid – see line 4 and formulation as a CNS-tropic viral vector – see line 5) is withdrawn in view of the amendment received August 3, 2026.
The objection to claim 8 regarding “of secretogranin II (scg2) polypeptide” should read “of a scg2 polypeptide” is withdrawn in view of the cancellation of the claim in the amendment received August 3, 2026.
The objection to claim 10 regarding personalization of inanimate objects is not typical of scientific writing (i.e. its – see lines 2 and 3). Appropriate correction is required is withdrawn in view of the cancellation of the claim in the amendment received August 3, 2026.
Maintained Objection
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraphs 296 (line 6) and 468 (page 136).
Arguments and Response
Applicants’ arguments directed to the objection to the specification were considered but are not persuasive for the following reasons.
Applicants contend that paragraph 295 (i.e. 296) does not contain browser executable code and that paragraph 468 does not exist.
Applicants’ arguments are not convincing since paragraph 296, line 6 contains browser executable code and paragraph 468 at page 136 of the specification contains browser executable code.
New Objection
Claim 1 is objected to because of the following informalities: two conjunctions are present in the same Markush group (“and” should be utilized with selected from the group consisting of). Appropriate correction is required.
Withdrawn Rejections
The rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the cancelation of the claim in the amendment received August 3, 2026.
The rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendment received August 3, 2026.
The rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendment received August 3, 2026.
The rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendment received August 3, 2026.
The rejection of claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the cancelation of the claim in the amendment received August 3, 2026.
The rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the cancelation of the claim in the amendment received August 3, 2026.
The rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the cancelation of the claim in the amendment received August 3, 2026.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the cancelation of the claim in the amendment received August 3, 2026.
The rejection of claim 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendment received August 3, 2026.
The rejection of claim 2 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the cancellation of the claim in the amendment received Augst 3, 2026.
The rejection of claim 7 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the amendment received Augst 3, 2026.
The rejection of claim 8 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the cancellation of the claim in the amendment received Augst 3, 2026.
The rejection of claim 10 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the cancellation of the claim in the amendment received Augst 3, 2026.
The rejection of claim 11 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the cancellation of the claim in the amendment received Augst 3, 2026.
The rejection of claim 13 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the cancellation of the claim in the amendment received Augst 3, 2026.
The rejection of claim 7 on the basis that it contains an improper Markush grouping of alternatives is withdrawn in view of the amendment received August 3, 2026.
The rejection of claims 1, 2, 7-11, 13, 14, 23, 89, and 91 under 35 U.S.C. 102(a)(1) as being anticipated by Steward et al. WO 2008/008805 published January 17, 2008 is withdrawn in view of the amendment received August 3, 2026.
The rejection of claims 1, 2, 7-11, 13, 14, 23, 89, and 90 under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. U.S. Patent Application Publication 2007/0116677 published May 24, 2007 is withdrawn in view of the amendment received August 3, 2026.
New Rejection Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 89-91, and 93 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a sequence that is at least 95% identical to one SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, or SEQ ID NO: 8”, and the claim also recites “selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8” (i.e. requiring 100% identity and the same length) which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 89-91, and 93 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring SCG2 neuropeptides fragments SEQ ID NOs: 5-8 without significantly more. The claims recite at least one SCG2 neuropeptide of SEQ ID NOs: 5-8 and a pharmaceutically acceptable carrier is a solution comprising a carrier protein. Dependent claims 89-91 and 93 refer to saline, PBS, BSA, and CRM197. This judicial exception is not integrated into a practical application because the present claims are drawn to a product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is unclear how the additional components are associated with the SCG2 neuropeptide (e.g. is a solution comprising a carrier protein does not refer to how the carrier protein is associated with the SCG2 neuropeptides fragments). In addition, carrier protein, solution, saline, PBS, BSA, and CRM197 are all well-understood, routine, and conventional in the prior art. Furthermore, SCG2 neuropeptides are found in the brain (i.e. already across the BBB).
SEQ ID NO: 5
RESULT 1
Q2ERU2_FELCA
ID Q2ERU2_FELCA Unreviewed; 114 AA.
AC Q2ERU2;
DT 21-MAR-2006, integrated into UniProtKB/TrEMBL.
DT 21-MAR-2006, sequence version 1.
DT 08-OCT-2025, entry version 36.
DE RecName: Full=Secretogranin-2 {ECO:0000256|ARBA:ARBA00013649};
DE AltName: Full=Secretogranin II {ECO:0000256|ARBA:ARBA00032429};
DE Flags: Fragment;
GN Name=SGII {ECO:0000313|EMBL:ABD24220.1};
OS Felis catus (Cat) (Felis silvestris catus).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Laurasiatheria; Carnivora; Feliformia; Felidae; Felinae; Felis.
OX NCBI_TaxID=9685 {ECO:0000313|EMBL:ABD24220.1};
RN [1] {ECO:0000313|EMBL:ABD24220.1}
RP NUCLEOTIDE SEQUENCE.
RC TISSUE=Adrenal medulla {ECO:0000313|EMBL:ABD24220.1};
RX PubMed=16101435; DOI=10.2174/1389203054546334;
RA Fischer-Colbrie R., Kirchmair R., Kahler C.M., Wiedermann C.J., Saria A.;
RT "Secretoneurin: a new player in angiogenesis and chemotaxis linking nerves,
RT blood vessels and the immune system.";
RL Curr. Protein Pept. Sci. 6:373-385(2005).
RN [2] {ECO:0000313|EMBL:ABD24220.1}
RP NUCLEOTIDE SEQUENCE.
RC TISSUE=Adrenal medulla {ECO:0000313|EMBL:ABD24220.1};
RA Fischer-Colbrie R., Reinalter H.;
RL Submitted (JAN-2006) to the EMBL/GenBank/DDBJ databases.
CC -!- FUNCTION: Neuroendocrine protein of the granin family that regulates
CC the biogenesis of secretory granules. {ECO:0000256|ARBA:ARBA00003092}.
CC -!- SUBUNIT: Interacts with Secretogranin III/SCG3.
CC {ECO:0000256|ARBA:ARBA00011376}.
CC -!- SUBCELLULAR LOCATION: Secreted {ECO:0000256|ARBA:ARBA00004613}.
CC -!- SIMILARITY: Belongs to the chromogranin/secretogranin protein family.
CC {ECO:0000256|ARBA:ARBA00005723}.
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DR EMBL; DQ366896; ABD24220.1; -; mRNA.
DR AlphaFoldDB; Q2ERU2; -.
DR GO; GO:0005576; C:extracellular region; IEA:UniProtKB-SubCell.
DR GO; GO:0030141; C:secretory granule; IEA:InterPro.
DR InterPro; IPR001990; Granin.
DR InterPro; IPR038858; ScgII.
DR PANTHER; PTHR15119; SECRETOGRANIN II; 1.
DR PANTHER; PTHR15119:SF0; SECRETOGRANIN-2; 1.
DR Pfam; PF01271; Granin; 1.
PE 2: Evidence at transcript level;
KW Cleavage on pair of basic residues {ECO:0000256|ARBA:ARBA00022685};
KW Secreted {ECO:0000256|ARBA:ARBA00022525};
KW Signal {ECO:0000256|ARBA:ARBA00022729}.
FT REGION 1..37
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT NON_TER 1
FT /evidence="ECO:0000313|EMBL:ABD24220.1"
FT NON_TER 114
FT /evidence="ECO:0000313|EMBL:ABD24220.1"
SQ SEQUENCE 114 AA; 13571 MW; 264A8C26181C7FE8 CRC64;
Query Match 100.0%; Score 167; Length 114;
Best Local Similarity 100.0%;
Matches 33; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TNEIVEEQYTPQSLATLESVFQELGKLTGPNNQ 33
|||||||||||||||||||||||||||||||||
Db 59 TNEIVEEQYTPQSLATLESVFQELGKLTGPNNQ 91
SEQ ID NO: 6
RESULT 1
Q8HZG7_9PRIM
ID Q8HZG7_9PRIM Unreviewed; 339 AA.
AC Q8HZG7;
DT 01-MAR-2003, integrated into UniProtKB/TrEMBL.
DT 01-MAR-2003, sequence version 1.
DT 08-OCT-2025, entry version 50.
DE RecName: Full=Secretogranin-2 {ECO:0000256|ARBA:ARBA00013649};
DE AltName: Full=Secretogranin II {ECO:0000256|ARBA:ARBA00032429};
DE Flags: Fragment;
OS Gorilla gorilla (western gorilla).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Euarchontoglires; Primates; Haplorrhini; Catarrhini; Hominidae;
OC Gorilla.
OX NCBI_TaxID=9593 {ECO:0000313|EMBL:AAM76549.1};
RN [1] {ECO:0000313|EMBL:AAM76549.1}
RP NUCLEOTIDE SEQUENCE.
RA O'hUigin C., Tichy H., Klein J.;
RT "Molecular evolution in higher primates; gene specific and organism
RT specific characteristics.";
RL Submitted (MAR-2002) to the EMBL/GenBank/DDBJ databases.
CC -!- FUNCTION: Neuroendocrine protein of the granin family that regulates
CC the biogenesis of secretory granules. {ECO:0000256|ARBA:ARBA00003092}.
CC -!- SUBUNIT: Interacts with Secretogranin III/SCG3.
CC {ECO:0000256|ARBA:ARBA00011376}.
CC -!- SUBCELLULAR LOCATION: Secreted {ECO:0000256|ARBA:ARBA00004613}.
CC -!- SIMILARITY: Belongs to the chromogranin/secretogranin protein family.
CC {ECO:0000256|ARBA:ARBA00005723}.
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DR EMBL; AY091931; AAM76549.1; -; Genomic_DNA.
DR AlphaFoldDB; Q8HZG7; -.
DR GO; GO:0005615; C:extracellular space; IEA:TreeGrafter.
DR GO; GO:0030141; C:secretory granule; IEA:InterPro.
DR GO; GO:0042056; F:chemoattractant activity; IEA:TreeGrafter.
DR GO; GO:0005125; F:cytokine activity; IEA:TreeGrafter.
DR GO; GO:0001525; P:angiogenesis; IEA:TreeGrafter.
DR GO; GO:0048245; P:eosinophil chemotaxis; IEA:TreeGrafter.
DR InterPro; IPR001990; Granin.
DR InterPro; IPR038858; ScgII.
DR PANTHER; PTHR15119; SECRETOGRANIN II; 1.
DR PANTHER; PTHR15119:SF0; SECRETOGRANIN-2; 1.
DR Pfam; PF01271; Granin; 1.
PE 3: Inferred from homology;
KW Cleavage on pair of basic residues {ECO:0000256|ARBA:ARBA00022685};
KW Secreted {ECO:0000256|ARBA:ARBA00022525};
KW Signal {ECO:0000256|ARBA:ARBA00022729}.
FT REGION 48..86
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT REGION 101..124
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT REGION 239..271
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 73..86
FT /note="Basic and acidic residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 239..265
FT /note="Basic and acidic residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT NON_TER 1
FT /evidence="ECO:0000313|EMBL:AAM76549.1"
FT NON_TER 339
FT /evidence="ECO:0000313|EMBL:AAM76549.1"
SQ SEQUENCE 339 AA; 39550 MW; 44AFCDEC0F7E7E50 CRC64;
Query Match 100.0%; Score 347; Length 339;
Best Local Similarity 100.0%;
Matches 66; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ERMDEEQKLYTDDEDDIYKANNIAYEDVVGGEDWNPVEEKIESQTQEEVRDSKENIEKNE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 198 ERMDEEQKLYTDDEDDIYKANNIAYEDVVGGEDWNPVEEKIESQTQEEVRDSKENIEKNE 257
Qy 61 QINDEM 66
||||||
Db 258 QINDEM 263
SEQ ID NO: 7
RESULT 1
I7GJU8_MACFA
ID I7GJU8_MACFA Unreviewed; 398 AA.
AC I7GJU8;
DT 03-OCT-2012, integrated into UniProtKB/TrEMBL.
DT 03-OCT-2012, sequence version 1.
DT 08-OCT-2025, entry version 26.
DE RecName: Full=Secretogranin-2 {ECO:0000256|ARBA:ARBA00013649};
DE AltName: Full=Secretogranin II {ECO:0000256|ARBA:ARBA00032429};
OS Macaca fascicularis (Crab-eating macaque) (Cynomolgus monkey).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Euarchontoglires; Primates; Haplorrhini; Catarrhini;
OC Cercopithecidae; Cercopithecinae; Macaca.
OX NCBI_TaxID=9541 {ECO:0000313|EMBL:BAE87653.1};
RN [1] {ECO:0000313|EMBL:BAE87653.1}
RP NUCLEOTIDE SEQUENCE.
RX PubMed=17194215; DOI=10.1371/journal.pbio.0050013;
RA Wang H.-Y., Chien H.-C., Osada N., Hashimoto K., Sugano S., Gojobori T.,
RA Chou C.-K., Tsai S.-F., Wu C.-I., Shen C.-K.J.;
RT "Rate of evolution in brain-expressed genes in humans and other primates.";
RL PLoS Biol. 5:e13-e13(2007).
CC -!- FUNCTION: Neuroendocrine protein of the granin family that regulates
CC the biogenesis of secretory granules. {ECO:0000256|ARBA:ARBA00003092}.
CC -!- SUBUNIT: Interacts with Secretogranin III/SCG3.
CC {ECO:0000256|ARBA:ARBA00011376}.
CC -!- SUBCELLULAR LOCATION: Secreted {ECO:0000256|ARBA:ARBA00004613}.
CC -!- SIMILARITY: Belongs to the chromogranin/secretogranin protein family.
CC {ECO:0000256|ARBA:ARBA00005723}.
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DR EMBL; AB170590; BAE87653.1; -; mRNA.
DR AlphaFoldDB; I7GJU8; -.
DR GO; GO:0005615; C:extracellular space; IEA:TreeGrafter.
DR GO; GO:0030141; C:secretory granule; IEA:InterPro.
DR GO; GO:0042056; F:chemoattractant activity; IEA:TreeGrafter.
DR GO; GO:0005125; F:cytokine activity; IEA:TreeGrafter.
DR GO; GO:0001525; P:angiogenesis; IEA:TreeGrafter.
DR GO; GO:0048245; P:eosinophil chemotaxis; IEA:TreeGrafter.
DR InterPro; IPR018054; Chromogranin_CS.
DR InterPro; IPR001990; Granin.
DR InterPro; IPR038858; ScgII.
DR PANTHER; PTHR15119; SECRETOGRANIN II; 1.
DR PANTHER; PTHR15119:SF0; SECRETOGRANIN-2; 1.
DR Pfam; PF01271; Granin; 1.
DR PROSITE; PS00422; GRANINS_1; 1.
PE 2: Evidence at transcript level;
KW Calcium {ECO:0000256|ARBA:ARBA00022837};
KW Cleavage on pair of basic residues {ECO:0000256|ARBA:ARBA00022685};
KW Phosphoprotein {ECO:0000256|ARBA:ARBA00022553};
KW Secreted {ECO:0000256|ARBA:ARBA00022525};
KW Signal {ECO:0000256|ARBA:ARBA00022729};
KW Sulfation {ECO:0000256|ARBA:ARBA00022641}.
FT REGION 38..62
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT REGION 331..364
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
SQ SEQUENCE 398 AA; 45533 MW; D774B806F66173F2 CRC64;
Query Match 100.0%; Score 200; Length 398;
Best Local Similarity 100.0%;
Matches 40; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VPGQGSSEDDLQEEEQIEQAIKEHLNQGSSQETDKLAPVS 40
||||||||||||||||||||||||||||||||||||||||
Db 308 VPGQGSSEDDLQEEEQIEQAIKEHLNQGSSQETDKLAPVS 347
SEQ ID NO: 8
RESULT 1
B4DQJ6_HUMAN
ID B4DQJ6_HUMAN Unreviewed; 477 AA.
AC B4DQJ6;
DT 23-SEP-2008, integrated into UniProtKB/TrEMBL.
DT 23-SEP-2008, sequence version 1.
DT 08-OCT-2025, entry version 57.
DE RecName: Full=Secretogranin-2 {ECO:0000256|ARBA:ARBA00013649};
DE AltName: Full=Secretogranin II {ECO:0000256|ARBA:ARBA00032429};
OS Homo sapiens (Human).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Euarchontoglires; Primates; Haplorrhini; Catarrhini; Hominidae;
OC Homo.
OX NCBI_TaxID=9606 {ECO:0000313|EMBL:BAG60958.1};
RN [1] {ECO:0000313|EMBL:BAG60958.1}
RP NUCLEOTIDE SEQUENCE.
RA Wakamatsu A., Yamamoto J., Kimura K., Ishii S., Watanabe K., Sugiyama A.,
RA Murakawa K., Kaida T., Tsuchiya K., Fukuzumi Y., Kumagai A., Oishi Y.,
RA Yamamoto S., Ono Y., Komori Y., Yamazaki M., Kisu Y., Nishikawa T.,
RA Sugano S., Nomura N., Isogai T.;
RT "NEDO human cDNA sequencing project focused on splicing variants.";
RL Submitted (OCT-2007) to the EMBL/GenBank/DDBJ databases.
CC -!- FUNCTION: Neuroendocrine protein of the granin family that regulates
CC the biogenesis of secretory granules. {ECO:0000256|ARBA:ARBA00003092}.
CC -!- SUBUNIT: Interacts with Secretogranin III/SCG3.
CC {ECO:0000256|ARBA:ARBA00011376}.
CC -!- SUBCELLULAR LOCATION: Secreted {ECO:0000256|ARBA:ARBA00004613}.
CC -!- SIMILARITY: Belongs to the chromogranin/secretogranin protein family.
CC {ECO:0000256|ARBA:ARBA00005723}.
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DR EMBL; AK298828; BAG60958.1; -; mRNA.
DR AlphaFoldDB; B4DQJ6; -.
DR PeptideAtlas; B4DQJ6; -.
DR GO; GO:0005576; C:extracellular region; IEA:UniProtKB-SubCell.
DR GO; GO:0030141; C:secretory granule; IEA:InterPro.
DR InterPro; IPR018054; Chromogranin_CS.
DR InterPro; IPR001990; Granin.
DR InterPro; IPR038858; ScgII.
DR PANTHER; PTHR15119; SECRETOGRANIN II; 1.
DR PANTHER; PTHR15119:SF0; SECRETOGRANIN-2; 1.
DR Pfam; PF01271; Granin; 2.
DR PROSITE; PS00422; GRANINS_1; 1.
PE 2: Evidence at transcript level;
KW Calcium {ECO:0000256|ARBA:ARBA00022837};
KW Cleavage on pair of basic residues {ECO:0000256|ARBA:ARBA00022685};
KW Phosphoprotein {ECO:0000256|ARBA:ARBA00022553};
KW Secreted {ECO:0000256|ARBA:ARBA00022525};
KW Signal {ECO:0000256|ARBA:ARBA00022729, ECO:0000256|SAM:SignalP};
KW Sulfation {ECO:0000256|ARBA:ARBA00022641}.
FT SIGNAL 1..27
FT /evidence="ECO:0000256|SAM:SignalP"
FT CHAIN 28..477
FT /note="Secretogranin-2"
FT /evidence="ECO:0000256|SAM:SignalP"
FT /id="PRO_5002800930"
FT REGION 91..162
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT REGION 411..443
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 92..105
FT /note="Basic and acidic residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 113..144
FT /note="Basic and acidic residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 153..162
FT /note="Basic and acidic residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
SQ SEQUENCE 477 AA; 54274 MW; DB3D8E6F60DC3042 CRC64;
Query Match 100.0%; Score 232; Length 477;
Best Local Similarity 100.0%;
Matches 42; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FPVGPPKNDDTPNRQYWDEDLLMKVLEYLNQEKAEKGREHIA 42
||||||||||||||||||||||||||||||||||||||||||
Db 429 FPVGPPKNDDTPNRQYWDEDLLMKVLEYLNQEKAEKGREHIA 470
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 101 as being drawn to a judicial exception claims 1, 89-91, and 93 were considered but are not persuasive for the following reasons.
Applicants contend that the new limitations of claim 1 (i.e. wherein the pharmaceutically acceptable carrier is a solution comprising a carrier protein that increases delivery across the BBB) negate the rejection based on markedly different structural and functional characteristics.
Applicants’ arguments are not convincing since applicants are interpreting the solution and carrier protein more narrowly than presently claimed. Scg2 neuropeptides are naturally found in the brain (i.e. solution, cerebrospinal solution, blood, etc.) and can alter the BBB (see Lin et al., 2024, SCG2 mediated blood-brain barrier dysfunction and schizophrenia-like behaviors after traumatic brain injury, The FASEB Journal, 38: e70016 (12 pages)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 89-91, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Steward et al. WO 2008/008805 published January 17, 2008; Toneff et al., 2013, Beta-amyloid peptides undergo regulated co-secretion with neuropeptide and catecholamine neurotransmitters, Peptides, 46: 21 pages; and Jones et al., 2007, Blood-Brain Barrier Transport of Therapeutics via Receptor-Mediation, Pharm Res, 24(9): 1759-1771.
For present claims 1, 89-91, and 93, Steward et al. teach SEQ ID NO: 87 (100% identity and the same length as present SEQ ID NO: 5), EM66, manserin (crosses the BBB), saline (i.e. pharmaceutically acceptable carrier), BSA (i.e. pharmaceutically acceptable carrier), and fusion polypeptides (please refer to the entire specification particularly paragraphs 218, 277, 286-289, 337, 345, 356, 362, 363, 379, 451; claim 46 in the specification).
However, Steward et al. do not teach PBS.
For present claims 1, 89-91, and 93, Toneff et al. teach peptides in a PBS-BSA solution (please refer to the entire reference particularly section 2.2).
However, Steward et al. do not teach CRM197.
For present claims 1, 89-91, and 93, Jones et al. teach methods of making peptide-CRM197 fusion polypeptides to cross the BBB (please refer to the entire specification particularly section IV Diphtheria toxin receptor/Heparin binding epidermal growth-factor-like growth factor – page 9).
All the claimed elements (i.e. PBS, CRM197 fusion polypeptides) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective function (i.e. PBS solution comprising a polypeptide; CRM197 fusion polypeptides can cross the BBB) and the combination would have yielded predictable results (i.e. polypeptide in a PBS solution; CRM197 fusion polypeptides can cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. saline; genus of fusion polypeptide) for another (i.e. PBS; CRM197 fusion polypeptide) would have yielded predictable results (i.e. peptide in a PBS solution; CRM197 fusion to cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. making peptide, PBS, and BSA solution; utilizing CRM197 peptide fusions to cross the BBB) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Steward et al.; Toneff et al.; and Jones et al. for claims 1, 89-91, and 93 were considered but are not persuasive for the following reasons.
Applicants contend that Steward et al. teaches modified Clostridial toxins comprising a Clostridial toxin enzymatic domain, a Clostridial toxin translocation domain, a translocation facilitating domain, and an altered targeting domain and not SEQ ID NO: 87 alone. Applicants contend that Stewart et al. does not refer to the BBB and no motivation is present. Applicants are also of the opinion that one of skill in the art would not add BSA.
Applicants’ arguments are not convincing since the teachings of Steward et al.; Toneff et al.; and Jones et al. render the composition of the instant claims prima facie obvious.
Steward et al. teach SEQ ID NO: 87 (100% identity and the same length as present SEQ ID NO: 5) as a stand-alone sequence (please refer to the entire specification particularly 286-289; sequence listing).
All the claimed elements (i.e. PBS, CRM197 fusion polypeptides) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective function (i.e. PBS solution comprising a polypeptide; CRM197 fusion polypeptides can cross the BBB) and the combination would have yielded predictable results (i.e. polypeptide in a PBS solution; CRM197 fusion polypeptides can cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. saline; genus of fusion polypeptide) for another (i.e. PBS; CRM197 fusion polypeptide) would have yielded predictable results (i.e. peptide in a PBS solution; CRM197 fusion to cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. making peptide, PBS, and BSA solution; utilizing CRM197 peptide fusions to cross the BBB) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Anyone that has spent any time in a biology lab would understand that BSA is an exceedingly common addition to polypeptide solutions. BSA is utilized for a variety of reasons including improving solubility, preventing aggregation, blocking nonspecific binding, and protecting peptides from degradation.
Claims 1, 89-91, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. U.S. Patent Application Publication 2007/0116677 published May 24, 2007; Toneff et al., 2013, Beta-amyloid peptides undergo regulated co-secretion with neuropeptide and catecholamine neurotransmitters, Peptides, 46: 21 pages; and Jones et al., 2007, Blood-Brain Barrier Transport of Therapeutics via Receptor-Mediation, Pharm Res, 24(9): 1759-1771.
For present claims 1, 89-91, and 93, Li et al. teach SEQ ID NO: 1 (100% identity and the same length as present SEQ ID NO: 5), carriers, PBS, and fusion polypeptides (please refer to the entire specification particularly the abstract; paragraphs 2, 3, 5-8, 10-14, 19, 21, 66). Li et al. also teach BSA, however, BSA is not in a formulation with the peptide (please refer to the entire specification particularly paragraphs 26).
However, Li et al. do not teach BSA in combination with a peptide.
For present claims 1, 89-91, and 93, Toneff et al. teach peptides in a PBS-BSA solution (please refer to the entire reference particularly section 2.2).
However, Li et al. do not teach CRM197.
For present claims 1, 89-91, and 93, Jones et al. teach methods of making peptide-CRM197 fusion polypeptides to cross the BBB (please refer to the entire specification particularly section IV Diphtheria toxin receptor/Heparin binding epidermal growth-factor-like growth factor – page 9).
All the claimed elements (i.e. BSA, CRM197 fusion polypeptides) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective function (i.e. BSA-PBS solution comprising a polypeptide; CRM197 fusion polypeptides can cross the BBB) and the combination would have yielded predictable results (i.e. polypeptide in a BSA-PBS solution; CRM197 fusion polypeptides can cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. PBS solution; genus of fusion polypeptide) for another (i.e. BSA-PBS solution; CRM197 fusion polypeptide) would have yielded predictable results (i.e. peptide in a PBS solution; CRM197 fusion to cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. making peptide, PBS, and BSA solution; utilizing CRM197 peptide fusions to cross the BBB) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Li et al.; Toneff et al.; and Jones et al. for claims 1, 89-91, and 93 were considered but are not persuasive for the following reasons.
Applicants contend that Li et al. do not teach a carrier protein that increases delivery across the BBB and no motivation is present. Applicants contend that since Li et al. teach intracerebral administration that one of skill in the art would never add a carrier protein that increases delivery across the BBB. Applicants contend that one of skill in the art would not add BSA to a solution.
Applicants’ arguments are not convincing since the teachings of Li et al.; Toneff et al.; and Jones et al. render the composition of the instant claims prima facie obvious.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
All the claimed elements (i.e. BSA, CRM197 fusion polypeptides) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective function (i.e. BSA-PBS solution comprising a polypeptide; CRM197 fusion polypeptides can cross the BBB) and the combination would have yielded predictable results (i.e. polypeptide in a BSA-PBS solution; CRM197 fusion polypeptides can cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (i.e. PBS solution; genus of fusion polypeptide) for another (i.e. BSA-PBS solution; CRM197 fusion polypeptide) would have yielded predictable results (i.e. peptide in a PBS solution; CRM197 fusion to cross the BBB) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. making peptide, PBS, and BSA solution; utilizing CRM197 peptide fusions to cross the BBB) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Paragraph 19 of Li et al. teaches that an appropriate administration route can be determined (i.e. other than intracerebral administration).
Anyone that has spent any time in a biology lab would understand that BSA is an exceedingly common addition to polypeptide solutions. BSA is utilized for a variety of reasons including improving solubility, preventing aggregation, blocking nonspecific binding, and protecting peptides from degradation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2008/020192
U.S. Patent Application Publication 2019/0314375
Prathipati et al., 2016, Development of novel HDL-mimicking a-tocopherol-coated nanoparticles to encapsulate nerve growth factor and evaluation of biodistribution, Eur J Pharm Biopharm, 108: 126-135.
Pillai et al., 1995, Immunogenicity of Genetically Engineered Glutathione S-Transferase Fusion Proteins Containing a T-Cell Epitope from Diphtheria Toxin, Infection and Immunity, 63(4): 1535-1540.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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